Abstract | BACKGROUND: The treatment of paraphilias, especially of pedophilia, centers upon cognitive-behavioral psychotherapy and pharmacologic interventions. Two open, uncontrolled clinical studies using the synthetic LHRH-agonist triptorelin suggested that, combined with psychotherapy, antiandrogen treatment reduced deviant sexual fantasies, urges, and behaviors in paraphilic patients. There is a need for further research using controlled, randomized trials to examine the effectiveness of sexual offender treatment including psychotherapeutic and pharmacologic interventions. OBJECTIVE: The aim of this pilot study is to evaluate the efficacy and tolerability of cognitive-behavioral psychotherapy together with intramuscular (IM) 3-monthly injections of triptorelin in adult men with severe pedophilia. STUDY DESIGN AND METHODS: In this multicenter, forensic psychiatric hospital-based, double-blind, controlled, parallel group phase IV trial conducted in Germany, convicted male sexual offenders aged ≥ 18 years with pedophilia, as defined by DSM-IV-TR criteria, will be randomized to receive study-specific psychotherapy together either with triptorelin or placebo for 12 months (total of 4 injections). This is a pilot study, therefore exploratory data analyses will be carried out of three different target parameters: 1. Changes in psychosexual characteristics using the Multiphasic Sex Inventory (scale: sexual abuse of children) 2. Changes in the risk of violent sexual behavior using the Sexual Violence Risk-20 total score 3. Changes in serum testosterone concentration Treatment effects will be assessed by comparing baseline values with those at the final examination (month 12). LIMITATIONS: The absence of real-life stimulants to test for actual recidivism limits possible findings. The study will be conducted in agreement with the European GCP-guideline, all relevant legal requirements, and the legal framework for voluntary treatment of convicted sexual offenders in Germany.
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Authors | Peer Briken, Wolfgang Berner, P278 study group |
Journal | The Israel journal of psychiatry and related sciences
(Isr J Psychiatry Relat Sci)
Vol. 49
Issue 4
Pg. 306-13
( 2012)
ISSN: 2617-2402 [Electronic] Israel |
PMID | 23585468
(Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Androgen Antagonists
- Triptorelin Pamoate
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Topics |
- Adult
- Androgen Antagonists
(administration & dosage, pharmacology)
- Clinical Protocols
- Combined Modality Therapy
- Criminals
- Double-Blind Method
- Humans
- Male
- Pedophilia
(drug therapy, therapy)
- Pilot Projects
- Psychotherapy
(methods)
- Sex Offenses
(prevention & control)
- Treatment Outcome
- Triptorelin Pamoate
(administration & dosage, pharmacology)
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